Video Intervention to Enhance the Safety Of Cognitively Impaired Older Drivers

Impaired Driving Clinical Trial

Official title:

Video Intervention to Enhance the Safety Of Cognitively Impaired Older Drivers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02593552
• Other study ID #: 263758-14
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: October 28, 2015
• Last updated: May 25, 2016
• Start date: September 2011
• Est. completion date: July 2014

Study information

• Verified date: May 2016
• Source: Rhode Island Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This pilot study was done to assess the feasibility and possible efficacy of a video feedback intervention to improve the safety of cognitively impaired older drivers.

Description:

The goals of this pilot study were to demonstrate that 1) g-force technology can effectively detect unsafe driving events by older adults, and 2) cognitively impaired older adults can improve their driving safety with an in-car video feedback intervention. Unsafe driving events were triggered by g-forces leading to capture of a video record that was then transmitted wirelessly to a remote office where the events were analyzed and scored. During the baseline phase (3 months), there was no feedback. During the intervention phase (4-6 months), participants received a weekly progress report in the mail along with DVD of recorded unsafe driving events with recommendations. The research team then contacted the participant and informant weekly to provide additional coaching, and verify that participants reviewed the information and videos. During the post-intervention monitoring phase (7-9 months), there was no further feedback. The primary quantitative outcomes were total number of unsafe driving events/1,000 miles and total safety driving score/1,000 miles. Secondary qualitative outcomes included the types and severity of unsafe driving events that were recorded.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 68 Years to 90 Years

Eligibility

Inclusion Criteria:

• age 60-90

• English speaking

• currently driving adults with a valid driving license and at least 10 years of driving experience

• neurological examinations judged to be normal for age or consistent with AD

• questionable to mild dementia (CDR 0.5 to 1)

• MMSE < 28

• have an adult family member or other caregiver, age >21 to participate in counseling feedback

Exclusion Criteria:

• ophthalmologic, physical, or neurologic disorders other than dementia that impair their driving abilities

• visual acuity worse than 20/40 in best eye using distance vision measured by wall chart

• homonymous hemianopia or bitemporal hemianopia on confrontation testing

• musculoskeletal disorders causing major physical handicaps such as frozen joints, inadequately healed fractures, and amputations

• history of alcohol or substance abuse by DSM V diagnostic criteria within the past year

• sedating medications that impair level of consciousness or attention

• language impairment that would interfere with the ability to participate in the educational intervention

• previous road test evaluation or opinion of caregiver or health professional that subject is unsafe to drive.

Related Conditions & MeSH terms

• Impaired Driving

Intervention

Device:
• DriveCam
Video event monitoring device

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rhode Island Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of unsafe driving events	Scale	9 months
Secondary	Severity score of unsafe driving events	Scale	9 months